NCT02168608

Brief Summary

Remote ischemia precondition could protect the liver from ischemia reperfusion injury in patients undergoing hepatectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

June 11, 2014

Last Update Submit

June 18, 2014

Conditions

Liver Neoplasms

Keywords

hepatic ischemia reperfusion injuryischemia preconditionremote ischemia preconditionanti-inflammation

Outcome Measures

Primary Outcomes (1)

  • survival rate

    30 days postoperatively

Secondary Outcomes (7)

  • alanine aminotransferase (ALT) level in patients' blood

    1 day postoperatively

  • aspartic transaminase (AST) level in patients' blood

    1 day postoperatively

  • alanine aminotransferase (ALT) level in patients' blood

    3 days postoperatively

  • aspartic transaminase (AST) level in patients' blood

    3 days postoperatively

  • alanine aminotransferase (ALT) level in patients' blood

    7 days postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Remote ischemia precondition

EXPERIMENTAL

patients in this arm accepted RIPC procedure after induction of anesthesia

Other: Remote ischemia precondition

None remote ischemia precondition

EXPERIMENTAL

patients in this arm didn't accept RIPC procedure after induction of anesthesia

Other: None remote ischemia precondition

Interventions

Remote ischemia preconditionOTHER

Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff placed on the right upper arm served as RIPC stimulus.

Remote ischemia precondition
None remote ischemia preconditionOTHER

Placed an uninflated cuff on the right upper arm for 30 min.

None remote ischemia precondition

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No other main organ diseases, American society of Anesthesiologists (ASA) classification Ⅰ-Ⅱ grade
  • Selective hepatectomy, one time hepatic portal occlusion
  • Child-Pugh A

You may not qualify if:

  • Peripheral vessels diseases
  • Not the same surgical procedure as expected
  • Administered anti-inflammatory drugs as glucocorticoid etc
  • Diagnosed of diabetes
  • History of liver surgery
  • History of hepatic interventional therapy, radiofrequency therapy,radiotherapy and chemotherapy
  • Refuse to join the research
  • Patients with psychopathy
  • Acute infection need antibiotic therapy
  • Hepatic artery or portal vein embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

Related Publications (5)

  • Kin H, Zhao ZQ, Sun HY, Wang NP, Corvera JS, Halkos ME, Kerendi F, Guyton RA, Vinten-Johansen J. Postconditioning attenuates myocardial ischemia-reperfusion injury by inhibiting events in the early minutes of reperfusion. Cardiovasc Res. 2004 Apr 1;62(1):74-85. doi: 10.1016/j.cardiores.2004.01.006.

    PMID: 15023554BACKGROUND

  • Huguet C, Addario-Chieco P, Gavelli A, Arrigo E, Harb J, Clement RR. Technique of hepatic vascular exclusion for extensive liver resection. Am J Surg. 1992 Jun;163(6):602-5. doi: 10.1016/0002-9610(92)90567-b.

    PMID: 1595841BACKGROUND

  • Delva E, Camus Y, Nordlinger B, Hannoun L, Parc R, Deriaz H, Lienhart A, Huguet C. Vascular occlusions for liver resections. Operative management and tolerance to hepatic ischemia: 142 cases. Ann Surg. 1989 Feb;209(2):211-8. doi: 10.1097/00000658-198902000-00012.

    PMID: 2916865BACKGROUND

  • Clavien PA, Yadav S, Sindram D, Bentley RC. Protective effects of ischemic preconditioning for liver resection performed under inflow occlusion in humans. Ann Surg. 2000 Aug;232(2):155-62. doi: 10.1097/00000658-200008000-00001.

    PMID: 10903590BACKGROUND

  • Azoulay D, Lucidi V, Andreani P, Maggi U, Sebagh M, Ichai P, Lemoine A, Adam R, Castaing D. Ischemic preconditioning for major liver resection under vascular exclusion of the liver preserving the caval flow: a randomized prospective study. J Am Coll Surg. 2006 Feb;202(2):203-11. doi: 10.1016/j.jamcollsurg.2005.10.021.

    PMID: 16427543BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Weifeng Yu, professor

    Eastern Hepatobiliary Surgery Hospital

    STUDY CHAIR

Central Study Contacts

Weifeng Yu, professor

CONTACT

86-10-81875231ywf808@sohu.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 20, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

June 1, 2016

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

CN(1)